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Devices
Device Recall ACUDRIVER
Model / Serial
Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
Product Description
Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
Manufacturer
Exactech, Inc.
1 Event
Recall of Device Recall ACUDRIVER
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Manufacturer
Exactech, Inc.
Manufacturer Address
Exactech, Inc., 2320 N.W. 66th Court, Gainesville FL 32653
Source
USFDA
Language
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